BEUDAMED
    FDA Adverse Event Summary report: N

    16" VAC STERILIZER

    MDR report key: 3232651 · Received July 18, 2013

    Report

    Report Number
    3005899764-2013-00072
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE SAFETY VALVE REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE SAFETY VALVE AND CONFIRMED THE UNIT TO BE OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR STERILIZER WAS LEAKING WATER. THE AMOUNT OF WATER THAT LEAKED WAS APPROXIMATELY ONE GALLON. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335482 16" VAC STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1